BMJ op-ed calls molnupiravir authorization ‘premature’

Image courtesy of Merck & Co.

A recent editorial in the British Medical Journal (BMJ) criticized the decisions of British and U.S. health regulators to authorize the use of the antiviral molnupiravir, the COVID-19 antiviral.

The developers of the drug, Merck & Co. (NYSE:MRK) and Ridgeback Biotherapeutics, had announced that molnupiravir lowered the risk of hospital admissions or death by roughly 50% in the 29 days following infection with COVID-19.

WHO recently updated its treatment guidelines to include the drug for high-risk individuals. The organization based its decision on new data from six randomized controlled studies involving 4,796 patients.

Authorizations of molnupiravir will “inhibit further necessary evaluations” and could divert funding from more effective treatments, argued author James M Brophy, a professor of medicine and epidemiology at McGill University Health Center.

Brophy noted that the FDA itself concluded that “it is reasonable to believe that molnupiravir may be effective,” arguing that the phrasing “raises questions about the strength and certainty of the evidence.”

Brophy concluded that the “published results have borderline significance, indicating that even a small number of misclassified outcomes could overturn the significance of the findings.”

Merck & Co. did not immediately respond to a request for comment.

Merck and Ridgeback Biotherapeutics had launched the MOVe-IN study for hospitalized COVID-19 patients and a Phase 3 MOVe-OUT study involving outpatients with COVID-19. Data from the latter was used for authorization.

Brophy also argued that the molnupiravir’s mutagenic mode of action could contribute to the emergence of new SARS-CoV-2 variants.

The WHO recommended active monitoring of the drug for safety.

NEJM profiled molnupiravir late last year.